Quality Engineer (Memphis)

Description : OVERVIEW

The Quality Engineer 1 is responsible for the design, development, and sustaining of quality processes and inspection methods, including procedures, gauging, programming, and documentation. This individual works with Quality Control, Product Development, and Manufacturing Operations Departments to support daily production, projects, and site initiatives. This individual is responsible for maintaining compliance of the quality system to internal and external medical device industry standards and regulation. This individual must have an eagerness to learn, understanding of manufacturing and quality principles, strong communication skills, technical proficiency in common software systems (Word, Excel, etc.), and a keen attention to detail. Experience in statistical analysis and / or software development and familiarity with Tulip, Jira, and Agile methodology is strongly preferred.

RESPONSIBILITIES

Develops various inspection techniques and procedures to ensure product integrity to design specifications.

Responsible for the writing, approval and implementation of Receiving, Floor and final Inspection procedures and operator self-inspection procedures.

Works with other Quality Engineers and the Metrology Lab personnel on the development and procurement of product gauging, optical comparator overlays, and templates.

Coordinates and executes the development of quality processes, which may include work instructions, procedures, gauges, overlays, test methods, etc.

Trains Manufacturing Associates in measuring, testing and inspection techniques.

Performs first article inspections, capability studies, process validations, and metallurgical analyses as necessary to characterize products, processes and materials.

Works with suppliers, engineers, and manufacturing associates in the resolution of quality problems, which may involve work on NCRs, material dispositions, compiling, trending, and analyzing quality data, and presentation of feedback to internal customers and external vendors suppliers.

EXPERIENCE AND REQUIREMENTS

Bachelors degree : Biomedical, Mechanical, Electrical, or related Engineering or Technical discipline.

0-2 years experience in a technical or manufacturing role preferred.

License / certification : ASQ CQE or Six Sigma Green Belt preferred

Competencies :

Must be able to communicate effectively, both verbally and in writing.

Effective project and time management, able to work independently and within a cross-functional team environment.

Requires proficiency using PC Applications including Microsoft Word, Minitab, PowerPoint, MS Project, Visio, and Excel.

Interacts with peers and management in other functional departments, as well as frequent interaction with production associates.

Also interacts with external suppliers of equipment and materials.

Physical Demands :

The Quality Engineer may spend approximately 1 / 3 of this time walking or standing.

The Quality Engineer may spend up to 60% of his time at a computer keyboard.

They must also be able to measure parts using hand instruments and lift up to 30lbs.

The Quality Engineer must be able to speak and hear well enough to communicate effectively.

Vision must be excellent or corrected.

Work Environment :

The Quality Engineer will not typically be exposed to a harsh or dangerous environment.

Noise level will be quiet to moderate.

The Quality Engineer may be exposed to noise, chemical, and mechanical hazards when working on the manufacturing floor and must wear appropriate PPE.